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Rx Drugs

Drug pricing is one of the only areas where the two parties and the president might find common ground to make laws, and President Donald Trump, Democrats and incoming Senate Finance chair have been harping on drug prices so long that it will be difficult for them to do nothing, according to two former White House health aides for Republican and Democratic administrations.

The International Consortium of Harmonisation agreed with FDA Commissioner Scott Gottlieb this month that its members should develop standard international approval requirements for generic drugs, which would facilitate simultaneous approvals in multiple markets.

Continuing drug shortage issues are a result of economic and policy failures that span many years, FDA Commissioner Scott Gottlieb told a crowd of researchers, health care providers, industry representatives and other experts during the agency’s Tuesday (Nov. 27) drug shortages public meeting, held in coordination with the Duke Margolis Center for Health Policy.

MS proposed Monday (Nov. 26) letting Part D plans exclude drugs in protected classes from Part D formularies when their makers raise prices faster than inflation or when drug companies make new formulations of drugs already on the market.

Oklahoma and CMS officials are scheduled to talk this week about whether the scope of the state’s Medicaid agreement allows for drug reimbursement over time, according to Becky Pasternik-Ikard, chief executive officer of Oklahoma's Medicaid agency.

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) on Tuesday (Nov. 20) unveiled a prescription drug-pricing bill that blends Republican and Democratic proposals: The legislative plan would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

Some lawmakers and congressional staff don’t expect a big legislative push for 340B reform in the next Congress, but Rep. Buddy Carter (R-GA) says he is optimistic his legislation to boost the program’s transparency and reporting could gather bipartisan support.

Kaleo CEO Spencer Williamson offered to lower the $4,100 price of the opioid overdose reversal drug Evzio as long as insurers give patients greater access to it, during his appearance on CBS’ “60 Minutes” on Sunday.

FDA Commissioner Scott Gottlieb said the agency hopes to boost its use of real-world evidence and other tools to analyze drug performance and support new indications, and he announced FDA will issue a framework to evaluate the use of RWE.

Incoming Senate Finance Committee chairman Charles Grassley (R-IA) and Senate Democratic Whip Dick Durbin (D-IL) on Friday asked the Trump administration to put in place by year’s end its proposal to require drug manufacturers disclose list prices in direct-to-consumer advertising, and they also called on HHS and CMS to adopt additional drug-price disclosure measures.

Sen. Charles Grassley (R-IA) is returning to chair the Finance Committee after a hiatus as Judiciary chair, and the move gives advocates for lower drug prices an ally on the committee with jurisdiction over Medicare and Medicaid that they do not have in the current Finance Chair Sen. Orrin Hatch (R-UT), who is retiring.

Lead sponsors Sens. Charles Grassley (R-IA) and Patrick Leahy (D-VT) are divided on whether they would still back a bill to support generic drug development if a pro-pharma provision were added to reverse changes Congress made to Medicare Part D payments in the coverage gap.

HHS Secretary Alex Azar doubled down on the Trump administration’s controversial plan to lower Medicare Part B drug costs by relying on international reference prices in a speech to the Commonwealth Fund International Symposium on Health Care Wednesday.